Many of you participated in the open concepts Request for Project Information (RPI) solicitation about nine months ago. As you may remember, this RPI was issued to gain ideas and expose new technologies that may influence how the DoD would spend their FY19 and 20 dollars. MTEC did an initial scrub to narrow down the number that the military would review. At the time, we were hoping to see either specific solicitations aligned to one topic/technology or perhaps a bundling of topics from an individual sponsor. Well, the results are in, and the bundling seems to be the chosen manner to move forward into formal solicitations.
The first move forward was the Combat Casualty Care multi-topic that was awarded at the end of September 2019. Initially, the thought was they would only use FY18 dollars (approximately $10M) for three to four topics. In actuality, the number of awards were greater than planned. Several projects were placed into the basket for potential funding with FY19 withhold dollars early in the new fiscal year. This “larger than expected” award outcome is based upon the quality submissions presented by consortium members.
We recently closed on the multi-topic from the Infectious Disease Research area which has four topic areas all aligned to submitted open concept papers. We received several proposals and the military is evaluating them as we speak with awards planned for late CY19 or early CY20.
The Military Operational Medicine sponsors are in discussions with Dr. Palestrini at the moment, and are working on a draft solicitation. In this instance, the open concept topics may be joined with new topic areas for a combined multi-topic solicitation. This solicitation could be out as early as November, so keep an eye out.
You have made the open concepts idea a success by submitting papers that attracted military interest, and now their dollars are flowing. The process of aligning military dollars to priority requirements can be a tenuous endeavor, as most dollars are firmly aligned prior to the start of any fiscal year. For the sponsors to make the realignment either shows that you hit the target of their needs or the technologies were so important the sponsors moved some of their funds onto your ideas. Either way, you as members should be congratulated for presenting cogent and feasible projects that met their needs.
We plan to request another round in the January/February timeframe in 2020, so look forward to another such action.
Chief Operating Officer, MTEC
FROM THE MTEC DIRECTOR OF PROGRAM OPERATIONS
2019 continues to be a year of significant growth for MTEC. Since MTEC’s founding, we have awarded a total of 56 projects with a funded ceiling of $174M. We put more funding on contract during the 3rd quarter of 2019 than we did all last year. We continue to expand our research topics and our funding sponsors. We are excited about our new relationship with the Navy and hope to start working with the Air Force in 2020.
MTEC has released 8 solicitations so far this calendar year:
Burn Patient Transfer System (BPTS)
Anti-Scar Treatment for Deep Partial-Thickness (DPT) Burns
Walter Reed Army Institute of Research (WRAIR) Small Molecule Antibiotic Drug Development for Combating Antibiotic Resistant Bacteria (CARB)
Development of Personalized Bacteriophage Therapeutic for the treatment of Bacterial Infections
Multi domain Life Saving Trauma Innovations (MuLTI)
Biomanufacturing for Regenerative Medicine (Biomfg)
Candidate Drug Treatment for Traumatic Brain Injury for Phase 2 Clinical Trials
Military Infectious Disease – Prototype Innovation Program
New Award Highlights:
MTEC has made the following awards recently:
19-01-BPTS: Chenega Healthcare Services
19-03-VML: 2 awards. Cedars Sinai and University of Pittsburgh
19-04-WRAIR-CARB: SRI International
19-05-Anti Scar: Tesa
19-06-Phage: Adaptive Phage Therapeutics
19-07-Biomfg: 3 awards. Southwest Research Institute, RegenMed Development Organization and University of Pittsburgh.
19-08-MuLTI: 5 awards. Platelet Biogenesis, Critical Innovations, Aptitude Medical Systems, Children’s Hospital of Philadelphia, Kitware. (3 additional awards pending)
Thank you for your continued support of MTEC – together we are working to protect and heal those who serve and I am excited about MTEC’s future.
POTENTIAL UPCOMING TOPIC AREAS OF INTEREST
MTEC understands the importance of sharing technical requirements as soon as possible with both members and to potential consortium members in order to allow the maximum possible time to prepare, team, and identify both public and private solicitation sponsors. Here is a list of topic areas of interest that may be incorporated into near-term funding opportunities.
Hemorrhage Detection focuses on the development of a noninvasive technology for early diagnosis and provider alert of decompensation due to hemorrhage and hemorrhagic shock in order to inform earlier lifesaving interventions and improve patient outcomes.
Post-traumatic Stress Disorder (PTSD) focuses on the development of a wearable, on-demand device for the management of symptoms associated with PTSD.
Fatigue management focuses on conducting tests to make recommendations that optimize Warfighter performance related to human-automation teaming.
Traumatic brain injury (TBI) focuses on the prevention of TBI by activating the human physiological response.
Brain Health focuses on the development of a brain health risk assessment for Warfighters that are exposed to environmental forces.
Regenerative Medicine focused on the development of scalable, production‐ready, commercial prototypes and processes for cell, tissue, or organ bioengineering technologies that will overcome current challenges and enable successful cGMP manufacturing and clinical translation of regenerative medicine based therapies.
Enhanced Readiness and Resilience of Navy and Marine Corps:
Prolonged and en route care focuses on patient care at and through the continuum of care as well as products and services that sustain patient health in austere environments such as expeditionary, littoral, and deep water.
Combat Casualty Care focuses on patient and personnel recovery, remote health monitoring, wound care, and immersion injuries.
Human Performance focuses on the prediction of health status and outcomes from various sources of combat related stressors and advanced biomedical electronics such as sensors and microelectronics.
Medical Logistics Enhancement focuses on resupply efficiencies and medical product stability.
Operational Readiness focuses on preventive measures against dental disease and optimization of baseline warfighter performance and resilience.
Risk & Safety Management focuses on developing and standardizing several modules for the identification of safety hazards to enhance human performance
Wearable Sensors focuses on monitoring heat strain in training.
For more information on upcoming solicitations, please reach out to MTEC’s Director of Research, Dr. Lauren Palestrini.
YOUR WORK MATTERS: HELPING THOSE WHO HAVE SERVED
We honor those who have served in the United States Armed Services. The work we do allows us to help injured warfighters and veterans, like Staff Sergeant Justin Lansford…
In 2012, Justin was serving as a squad leader and machine gunner in Afghanistan, when an improvised explosive device exploded under his truck. His truck flipped over completely. He had bilaterally severed femurs, resulting in the amputation of his left leg.
Despite his injuries, and with the help of 16 different specialized prosthetics, Justin continues to live a full and adventurous life that includes regular workouts, running, mountain climbing, and scuba diving.
As members of MTEC, we are paving the way to make sure our warfighters get innovative care for their injuries. One focus is on the development of robust manufacturing processes for new regenerative medicine therapies. The field of regenerative medicine uses biological engineering approaches to restore the structure and function of damaged tissues and organs by stimulating the patient’s own body to heal itself, or “regenerate.” This may provide a means to grow back limbs for the approximately 1,700 men and women who lost them in the most recent conflicts. As a nonprofit organization, we are asking for your support this Veterans Day, so that we may further fund innovative research in regenerative medicine.
Please consider making a donation or sharing this with those who want to honor the men and women of the U.S. military who fought for our country.
MTEC is always looking for innovative ways to share information about other members in the consortium, with the goal of increasing teaming for solicitations and partnering in general. We are happy to announce the creation of a teaming newsletter that provides members the opportunity to present a brief overview of their company and core service or product capability, as well as a timely collaboration area of interest.
The Teaming Newsletter will provide up to date information on collaboration interests by membership and contact information for connecting. We will have several calls throughout the year for collaboration requests, collecting them to include in the newsletter. We received a very good response back from the membership for this most recent request and will be sending out the first newsletter in November. We hope you will take advantage of this service as part of our on-going efforts to help you find the right collaboration partners for solicitations, project work, and potential partnerships beyond MTEC.
As a reminder MTEC also has established a collaboration database for members to access and discover the capabilities and collaboration interests of other members. Thank you to all the members who have completed their profile. We would like to remind all members to review and update their profile here.
For information about the teaming newsletter, reach out to MTEC’s Director of Commercialization, Rick Satcher.
THE TRAVELING MTEC BOOTH
Written by: William Howell, Chief Operating Officer
MTEC has been making the rounds the past quarter in trying to raise awareness for both company outreach and philanthropic purposes. Here are a few highlights:
VFW: In late July we went to Orlando for the Veterans of Foreign Wars annual convention. The VFW is famous for its camaraderie, the bond felt between all the members who have served our country.
But their sense of service didn’t stop when they were out of uniform. It continues in the form of the programs they provide to all who have served: programs like “Unmet Needs” that help financially distressed military members, their work to restore hearing, and their award of scholarships for continuing education. At the conference, many vets come together and tell their stories of combat and service. They shared with us many poignant memories of their exploits during Vietnam and the Southwest Asia engagements, and you could not help but believe in their supreme sacrifice and dedication to our nation. We also heard of lengthy hospital stays and lingering PTSD/TBI challenges for those who remain in care long after their service. Many Vietnam Vets, like the couple to the right from Florence SC, recognized the good that MTEC is doing for the next generation of warfighters. They gave us their approval and a few dollars to assist the effort.
MHSRS: Three weeks later, we were back in Orlando for the Military Health System Research Symposium (MHSRS) where we were a part of the large collection of companies demonstrating their commitment to the military medical mission. We had a very good session with several current members stopping by the booth. We assisted them in meeting military personnel and discussed ongoing efforts that could be of benefit. In addition, we met several new companies; many have subsequently become members – so welcome aboard! Our co-hosted reception again went long because of the great participation from several military and members, so our thanks for making it happen. This continues to be the largest medical related conference for the military, and their efforts make it a must stop for the MTEC. We saw more and more military directing companies to our booth; a sign that we have become an accepted entity within the military’s research mission.
Advamed MedTech Conference: The medical device industry’s largest association (Advamed) puts on a very strong conference every fall. This year’s conference took place in Boston in September. The program includes major company CEOs participating in many “lessons learned” type panels that assist everyone in the industry to understand the trials and tribulations of developing and marketing medical devices. This year, there was again a large contingent of small companies who had an innovation section with company kiosks. Additionally, the MTEC served as a participant in the first day small business meeting (run by MedTech Innovator and Advamed Accel programs). This relationship with both MedTech Innovator and the Advamed staff paid dividends as they drove people to our booth. I am proud to state that several visiting companies have since joined the MTEC. This was a successful conference for us!
AUSA: The Association of the US Army holds a large conference every October in Washington DC with more than 100 large defense industry vendors displaying their new wares oriented toward military use. From missiles to trucks to helicopters (yes helicopters!), the booths were quite extensive and interesting to both the military and civilians. I am afraid our smaller MTEC booth got a bit drowned in comparison to the scope and toys on display (in the photo, we are just to the left of the AUSA Pavilion sign), but due to the large number of conference attendees, we still had a reasonably decent flow of traffic at the booth.
We used the opportunity to focus on our Lives Restored program, drawing on the unmet medical research needs in hopes of raising some philanthropic dollars. We passed out large numbers of CFC postcards, and we hope to see the return at the start of the new calendar year.
Health Research Alliance: MTEC attended the Fall 2019 Health Research Alliance members’ meeting in Alexandria, VA. The meeting covered the following topics:
Effective Approaches to Increase Diversity and Inclusion in the Biomedical Research Workforce
Translating the Microbiome: Past, Present, and Future
Creating Networking and Partnering Opportunities
The Role of the Funder in Providing Mentoring Experiences for Grantees
Fact vs. Fiction
The meeting provided a great forum to network with other non-profit organizations funding biomedical science. We hope that this provides a springboard of new potential co-funding partnerships downstream.
It is important that MTEC be visible to the marketplace and our military community. The more people become aware of us, I think we will see greater use of our OTA contracting vehicle. Although the short term gains in some venues may not have been as large as desired, the overall impact cannot help but be positive. Look for us next year as we make the rounds to many of the major military and medical research symposia
OTHER TRANSACTION AGREEMENTS WITH THE MEDICAL TECHNOLOGY ENTERPRISE CONSORTIUM
MTEC, in conjunction with the Headquarters Office at the U.S. Army Medical Research and Development Command (USAMRDC) and the U.S. Medical Research Acquisition Activity (USAMRAA), conducted a workshop at USAMRDC in Fort Detrick, MD, in early October. The presenters discussed the use of Other Transaction Agreements with the MTEC as a tool to leverage industry/academic expertise to support Warfighter readiness and military medical needs. Also discussed were the roles and responsibilities of the Government Sponsor/PM/SOTR, USAMRAA and MTEC during the pre- and post-award stages. The group addressed frequently asked questions in the areas of Intellectual Property, Data Rights, ACURO and HRPO processes and the pros and cons of the various solicitation types available through the Other Transaction Agreements. The workshop was well attended by funding sponsors who currently use MTEC and those looking to learn more about MTEC. If you are a current or potential funding sponsor and would like MTEC to conduct this workshop at your organization, please reach out to: firstname.lastname@example.org
TODAY’S COMBINED FEDERAL CAMPAIGN:
Making it easy to contribute to good causes
The Combined Federal Campaign is in motion again and invitations are coming in for MTEC to meet federal employees from a variety of agencies. Before cell phones were in use (can you really imagine your life without them?), and before you could use the Internet to search or purchase items, convincing employees in the federal workplace was described as an “uncontrolled free for all.” None of the parties involved were happy. The agencies tried to apply pressure on the employees, the employees were not able to designate where their money should go and, as a result of the unstructured campaign, contributions were few and far between.
Today, CFC is the world’s largest and most successful annual workplace charity campaign, with almost 200 CFC campaigns throughout the country and overseas raising millions of dollars each year. The pledges made by Federal civilian, postal and military donors during the campaign season support eligible non-profit organizations that provide health and human service benefits throughout the world.
MTEC was pleased to accept an invitation for the 2019-2020 season to the Washington DC NASA CFC kick off which was well attended. We also attended an event at the US Customs House/Smithsonian in New York.
The CFC will go through January 12, 2020.
Last year, the campaign was interrupted by the government shutdown but the campaign coordinators expect to operate at full steam ahead this year.
Issued by President Reagan, the order initiating the Combined Federal Campaign states that a CFC objective is “to lessen the burdens of government and of local communities in meeting needs of human health and welfare …”
MTEC’s mission is to protect and heal through medical innovations, lessening the burden on the government and providing donors an opportunity to help meet the needs of our wounded military.
FIGHT FOR SIGHT SEEKING APPLICATIONS TO CO-FUND A POST-DOCTORAL AWARD WITH MTEC
Making it easy to contribute to good causes
MTEC is excited to announce a current funding opportunity related to prototype work linked to optic nerve regeneration and traumatic eye injury. MTEC and Fight for Sight are currently seeking applications to make one post-doctoral award, which will be equally co-funded. Applications are due November 15, 2019. To submit an application, visit: http://www.fightforsight.org/Grants/Application/
“Post-doctoral awards support individuals with a doctorate (Ph.D., M.D., O.D., Dr.PH, or D.V.M.) who are interested in academic careers in basic or clinical research in ophthalmology, vision or related sciences. This funding is intended to offer those interested in an academic career the opportunity to spend a year engaged in vision and eye research under the supervision of a senior scientist/clinician mentor. Clinical post-doctoral researchers are required to spend sufficient time on the funded research project to carry out the proposed objectives while basic researchers are expected to work full-time. One year grants of $22,500 are awarded for start dates between July 1 and September 1. Recipients may supplement their awards with institutional or other funds however any anticipated supplemental support must be disclosed at the time of application. Total combined salary support must not exceed the annual stipend level set by the NIH for National Research Service Award recipients. Fringe benefits are not provided. Applications are considered from individuals who are within three years of their doctoral degrees or clinical residency training and have not received a previous Fight for Sight fellowship award. If at the time of application a doctorate has not yet been obtained, the conferring institution must submit a cover letter advising when such degree is expected to be awarded.” For more information, visit: https://www.fightforsight.org/
MTEC RESEARCH UPDATE
Remodeling of Nanocomposite Bone Cements in a Rabbit Femoral Condyle Defect Model
Dr. Scott Guelcher and colleagues [M.A.P. McGough, D. Groff, J.S. Nyman, C.L. Duvall] at Vanderbilt University, in conjunction with collaborators at the U.S. Army Institute of Surgical Research [J. Wenke], and Medtronic Spine and Biologics [C. Rhodes and D.A. Shimko], have recently designed a novel biomaterial that aims to stabilize fractures while remodeling to form new bone, and demonstrated proof-of-concept in a rabbit bone defect model. This project was awarded through MTEC’s Regenerative Medicine Request for Project Proposals (16-01-REGEN).
The design of biomaterials that mechanically stabilize fractures while remodeling to form new bone is an unmet challenge in bone tissue engineering. The team has designed nanocrystalline hydroxyapatite (nHA)-poly(thioketal urethane) (PTKUR) bone cements that exhibit mechanical properties exceeding those of trabecular bone and undergo cell-mediated oxidative resorption. nHA-PTKUR cements were implanted in femoral plug defects in rabbits and the formation of new bone and cartilage evaluated by histology at 4, 12, and 18 months. As expected, intramembranous ossification was observed near the periphery of the cement at 4 months (Fig. A), as evidenced by osteoclast-mediated resorption of nHA-PTKUR (double arrow), osteoid (single arrow), and new bone (*). However, intramembranous ossification is limited to the host bone-cement interface and proceeds slowly. Surprisingly, endochondral ossification was also observed in the interior of the cement at 12 months (Fig. B), as evidenced by cartilage (pink, single arrow) and bone (green, double arrow) nodules. Endochondral ossification of nHA-PTKUR in response to oxidative degradation by infiltrating chondrocytes is anticipated to maintain structural support while promoting remodeling at a rate aligned with patient biology. Packaging configurations, stability-indicating methods, and kg-scale manufacturing processes have been developed to support a regulatory filing.
Congratulations to the team at the University of Pittsburgh for its new MTEC award, entitled “Enhanced Biologic Scaffold for Volumetric Muscle Loss”
The University of Pittsburgh (led by Dr. Stephen Badylak) has recently received an MTEC award to treat volumetric muscle loss (VML) through MTEC’s VML Request for Project Proposals (19-03-VML). Surgical mesh materials composed of extracellular matrix (ECM) can promote functional tissue remodeling by mechanisms that include stem cell maturation and differentiation and modulation of the host immune response toward a regulatory, pro-healing phenotype. From 2011 to 2015, the team conducted a thirteen-patient human cohort study in which ECM surgical meshes (including XenMatrix™) were used to treat VML. Results showed significant restoration of vascularized, innervated, and functional skeletal muscle with a marked improvement in the quality of life for all patients. In this MTEC-funded project, the team will: 1) Determine efficacy of an antibiotic-coated ECM surgical mesh (XenMatrix™ AB) for the promotion of muscle regeneration in human patients, and 2) Evaluate alternative antibiotic coatings in preclinical rodent models.
A bioscaffold/surgical mesh composed of porcine dermal ECM (XenMatrix™) was implanted at a site of volumetric muscle loss and can be visualized by MRI. The dark area in the left image represents the appearance of the mesh one month after surgery. The image on the right shows the MRI signal to be almost indistinguishable from adjacent normal muscle.
Advancing Regenerative Medicine Manufacturing Solutions: Paving the Way for New Regenerative Medicine Products
The RegenMed Development Organization (ReMDO) manages an industry-driven consortium and develops regenerative medicine manufacturing solutions in the precompetitive space. Two currently funded programs include developing a universal media to support clinical cell manufacturing and developing a tunable bioink to support 3D bioprinting / biomanufacturing.
Both programs were awarded through MTEC’s Regenerative Medicine Request for Project Proposals (16-01-REGEN). Each of these programs is driven by partnering with industry to advance platform technologies. Recent advances made by each of these programs will be highlighted briefly below.
Recent accomplishments for the ReMDO Media Program include developing several base media formulations to support cell growth. In addition to developing the base media, we have engineered supplements to grow challenging cells, and have also developed a commercialization strategy. We have also worked with our industry collaborators to generate media for real-world testing by both internal and external collaborators.
Recent accomplishments for the ReMDO Bioink Program include developing bioink formulations for specific tissue types, developing bioink supplements for challenging cell types, and engineering base bioink formulations for 3D printing / additive manufacturing. We are currently applying the same strategy to different printer platforms. In addition, we are developing standard operating procedures for different bioengineering technologies.
MTEC looks forward to the advancement in regenerative medicine manufacturing platform technologies by these programs, which will aid in bringing new regenerative medicine products to both the wounded warriors and the civilian population.
SHOP WITH AMAZON SMILE AND CONTRIBUTE TO MTEC
As we embark on the holiday shopping season, now is the perfect time to choose MTEC as your charity of choice at smile.amazon.com. AmazonSmile Foundation will donate 0.5% of the purchase price of eligible products to a charity of your choosing. By selecting MTEC, you’ll be supporting injured warfighters who have served this country. There is no cost to you, and it’s easy to sign up.
You can increase donations for MTEC by encouraging your friends and family to do their Amazon shopping at smile.amazon.com, too. Turn your holiday shopping dollars into donations!